Alzheimer's DiseasePhase 2EHT0202/002NCT00880412
A Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 as Adjunctive Therapy to Acetylcholinesterase Inhibitor in Mild to Moderate Alzheimer's Disease
A Phase 2 study testing EHT 0202 etazolate in people with Alzheimer's Disease, run by Exonhit at 22 sites in France.
Trial summary
The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- EHT 0202 etazolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 22 sitesFrance
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory male or female patient, aged 60-90 years old included at screening, and living at home.
- Patient having a clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Mild to moderate AD with a MMSE total score ≥ 12 and ≤ 24 at screening.
- Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. The caregiver will also have to sign a specific informed consent form regarding his/her participation in the study.
- Patient treated for AD treatment with one AChEI (donepezil, galantamine, or rivastigmine), according to the recommended posology mentioned in the summary of product characteristics, for at least 3 months and with a stable dose for at least 2 months prior to screening. The dose should be kept unchanged throughout the study duration.
- Patient with a cerebral CT-scan or cerebral MRI compatible with AD diagnosis, with no brain lesions that may be related to another diagnosis and that could be responsible for the current patient's condition (ex, but not limited to, non-AD dementia, brain injury, brain tumour, stroke, normal pressure hydrocephalus,…). A cerebral CT-scan or cerebral MRI has to be performed and results have to be available prior patient's randomization if the results of the brain imagery performed to settle the AD diagnosis are not available in the patient's file. Brain imaging has also to be performed if considered necessary by the investigator, such as in case of emerging neurological symptoms or in case of worsening of existing neurological symptoms.
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- Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD.
- No contra-indication to AChEI treatment and absence of significant adverse events considered to be related to AChEI treatment at screening and randomisation.
- Patient and patient's caregiver able to comply with study procedures, notably regarding the drug intake at the end of the meal which has to be supervised by the caregiver or another competent person.
Who cannot join
- Diagnosis of vascular dementia according to NINDS-AIREN criteria, or other non-AD dementia, or CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy,multiple sclerosis,…) that may be responsible for dementia.
- Clinically significant pathology and/or uncontrolled condition, including but not limited to cancer, infectious (like AIDS), gastro-intestinal, hepatic, renal, respiratory, endocrine(like diabetes mellitus, thyroiditis) pathology.
- History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders) that may interfere with study assessments.
- Current major depressive disorder, either treated or not, associated with clinically significant symptoms.
- Low blood level of vitamin B12, TSH levels out of normal range at screening.
- Current forbidden medication intake or intake within 2 weeks prior to screening.
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- Recent history (within the past year prior to inclusion) or current cardiovascular pathology and/or symptoms considered as clinically significant, including but not limited to angina pectoris, uncontrolled arrhythmia, significant ECG abnormalities. Lifetime history of heart failure, myocardial infarction, severe and/or uncontrolled angina pectoris,and/or ventricular arrhythmia disqualifies the patient.
- History or presence of clinically conditions that may interfere with product metabolism or with study assessments.
- Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg at screening and/or randomisation.
- QTc interval (Bazett's correction) ≥ 430 msec for male and ≥ 450 msec for female at screening.
- Laboratory values (biochemistry, haematology, urinalysis) considered as clinically significant and/or that may interfere with study assessments, according to the investigator.
- ALAT, ASAT, ALP > 2.5 times the upper normal limit (UNL), total bilirubin > 1.5 UNL or history of significant liver pathology including hepatitis caused by drugs, HBV, HCV.
- BUN, creatinin > 1.5 UNL.
- Current or recent history of drug or alcohol abuse or dependence.
- Patient not registered at "Sécurité Sociale".
- Participation in another study within 1 month prior to screening and during the whole duration of the study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Hôpital Privé Les Magnolias
Ballainvilliers, 91160
Cabinet Médical
Bergerac, 24100
Fleyriat Hospital
Bourg-en-Bresse, 01012
Cabinet Médical
Dijon, 21000
Charles Foix Hospital
Ivry-sur-Seine, 94026
Cabinet Médical
La Seyne-sur-Mer, 83500
Roger Salengro Hospital
Lille, 59037
Dupuytren Hospital
Limoges, 87042
Clinique Léopold Bellan
Magnanville, 78200
Cabinet Médical
Montpellier, 34070
Cabinet Médical 2
Montpellier, 34080
CHU Nantes Hôpital Laennec
Nantes, 44093
Cabinet Médical 2
Nice, 06000
Cabinet Médical
Nice, 06000
CHU Cochin Broca
Paris, 75013
Cabinet Médical
Rambouillet, 78120
CHU Rennes
Rennes, 35033
Cabinet Médical
Rodez, 12000
Cabinet Médical
Rueil-Malmaison, 92500
Cabinet Médical
Saint-Brieuc, 22000
Cabinet Médical
Toulon, 83000
Purpan-Casselardit Hospital - University of Toulouse
Toulouse, 31059
About this study
Official title: A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)
The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.
Read the detailed description
The aim of this pilot study is to assess the safety and tolerability profile of 2 doses of EHT 0202 (40 mg and 80 mg b.i.d) versus placebo in addition to a treatment with acetylcholinesterase inhibitor and its exploratory efficacy on cognition, behavior, activities of daily living, caregiver's burden and patient's global assessment, during a 3-month treatment period.
- Conditions
- Alzheimer's Disease
- Being tested
- EHT 0202 etazolate, Placebo
- Keywords
- safety, efficacy, Alzheimer's disease, treatment, phase II, study, cholinesterase inhibitor
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHT 0202 etazolateDrug
Also called EHT 0202, etazolate
In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
PlaceboDrug
In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
| Study group | Role | What they receive |
|---|---|---|
| EHT 0202 40 mg bid | Experimental | study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) Receives: Drug: EHT 0202 etazolate |
| EHT 0202 80 mg bid | Experimental | study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) Receives: Drug: EHT 0202 etazolate |
| placebo bid | Placebo comparator | study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence/frequency and severity of adverse events, relation to treatment start and drug exposure, drop-out rate, including reason for withdrawal, clinical examination, change from screening of biological safety parameters, vital signs, ECG and weight.
Measured: all study visits
Secondary outcomes (1)
Assessment of cognition (ADAS-Cog, Neuropsychological Test Battery, MMSE), patient's global functioning (CDR-SB,CGI), patient's behaviour (NPI), daily living activities (ADCS-ADL) and caregiver's burden. Population PK of EHT 0202 and PK/PD profile.
Measured: at the end of the 3-month study treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exonhit
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno Vellas, MD, Principal investigator, Casselardit Hospital - University of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880412
- Sponsor's protocol ID
- EHT0202/002
- Acronym
- EHT0202/002
- Status last verified
- Sep 2009
- First submitted
- 10 Apr 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)
- ClinicalTrials.gov ID
- NCT00880412
- Acronym / sponsor ID
- EHT0202/002 / EHT0202/002
- Conditions
- Alzheimer's Disease
- Keywords
- safety, efficacy, Alzheimer's disease, treatment, phase II, study, cholinesterase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- ExonhitIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.
Detailed description
The aim of this pilot study is to assess the safety and tolerability profile of 2 doses of EHT 0202 (40 mg and 80 mg b.i.d) versus placebo in addition to a treatment with acetylcholinesterase inhibitor and its exploratory efficacy on cognition, behavior, activities of daily living, caregiver's burden and patient's global assessment, during a 3-month treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EHT 0202 40 mg bid | Experimental | Drug: EHT 0202 etazolatestudy treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) |
| EHT 0202 80 mg bid | Experimental | Drug: EHT 0202 etazolatestudy treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) |
| placebo bid | Placebo comparator | Drug: Placebostudy treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ambulatory male or female patient, aged 60-90 years old included at screening, and living at home.
- Patient having a clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Mild to moderate AD with a MMSE total score ≥ 12 and ≤ 24 at screening.
- Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. The caregiver will also have to sign a specific informed consent form regarding his/her participation in the study.
- Patient treated for AD treatment with one AChEI (donepezil, galantamine, or rivastigmine), according to the recommended posology mentioned in the summary of product characteristics, for at least 3 months and with a stable dose for at least 2 months prior to screening. The dose should be kept unchanged throughout the study duration.
Key exclusion criteria (16 listed)
- Diagnosis of vascular dementia according to NINDS-AIREN criteria, or other non-AD dementia, or CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy,multiple sclerosis,…) that may be responsible for dementia.
- Clinically significant pathology and/or uncontrolled condition, including but not limited to cancer, infectious (like AIDS), gastro-intestinal, hepatic, renal, respiratory, endocrine(like diabetes mellitus, thyroiditis) pathology.
- History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders) that may interfere with study assessments.
- Current major depressive disorder, either treated or not, associated with clinically significant symptoms.
- Low blood level of vitamin B12, TSH levels out of normal range at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHT 0202 etazolateAlso: EHT 0202, etazolateIn each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment. | Drug | EHT 0202 40 mg bid, EHT 0202 80 mg bid |
| PlaceboIn each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment. | Drug | placebo bid |
Primary outcome
incidence/frequency and severity of adverse events, relation to treatment start and drug exposure, drop-out rate, including reason for withdrawal, clinical examination, change from screening of biological safety parameters, vital signs, ECG and weight.
Time frame: all study visits
1 secondary outcome
Assessment of cognition (ADAS-Cog, Neuropsychological Test Battery, MMSE), patient's global functioning (CDR-SB,CGI), patient's behaviour (NPI), daily living activities (ADCS-ADL) and caregiver's burden. Population PK of EHT 0202 and PK/PD profile.
Time frame: at the end of the 3-month study treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Vellas, MD principal investigator
Casselardit Hospital - University of Toulouse
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EHT 0202 etazolate in people with Alzheimer's Disease, run by Exonhit at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence/frequency and severity of adverse events, relation to treatment start and drug exposure, drop-out rate, including reason for withdrawal, clinical examination, change from screening of biological safety parameters, vital signs, ECG and weight. (time frame: all study visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.